Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID 83c592b4-4b17-4fe1-91ec-778c949e6196
Route
TOPICAL
Published
Effective Date 2018-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (0.2 g)
Inactive Ingredients
Acetone Diethylene Glycol Monoethyl Ether Propylene Glycol Alcohol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-10-01

Description

Active Ingredients:             Purpose Miconazole Nitrate 2%..... Antifungal


Medication Information

Warnings and Precautions


Warnings

For external use only

Flammable:Contents under pressure. Do not puncture or incinerate or store at a temperature above 120 degrees F. Use only as directed. intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or while smoking.



Indications and Usage

Uses

Proven clinically effective in the treatment of most:

  • athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)

For effective relief of:

  • itching
  • cracking
  • burning
  • scaling
  • discomfort
Dosage and Administration

Directions

  • clean the affected area and dry thoroughly
  • shake can well before use: Hold can about 6 inches from the area to be treated.
  • apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product



Athlete's Foot and Ringworm - use daily for 4 weeks

Jock Itch - use daily for 2 weeks

If condition persists longer, consult a doctor

This product is not effective on the scalp or nails For athlete's foot:

  • pay special attention to the spaces between the toes
  • wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
Description

Active Ingredients:             Purpose Miconazole Nitrate 2%..... Antifungal

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use

  • for diaper rash
  • on chuldren under 2 years of age

When using this product avoid contact with the eyes

S top use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Section 51727-6

Inactive ingredients acetone, ethoxydiglycol, propylene glycol, SD alcohol 40-B (74% w/w), tocopheryl acetate

Section 51945-4

Section 53413-1

Questions or comments?



Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredients:             Purpose

Miconazole Nitrate 2%..... Antifungal




Structured Label Content

Indications and Usage (34067-9)

Uses

Proven clinically effective in the treatment of most:

  • athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)

For effective relief of:

  • itching
  • cracking
  • burning
  • scaling
  • discomfort
Dosage and Administration (34068-7)

Directions

  • clean the affected area and dry thoroughly
  • shake can well before use: Hold can about 6 inches from the area to be treated.
  • apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
  • supervise children in the use of this product



Athlete's Foot and Ringworm - use daily for 4 weeks

Jock Itch - use daily for 2 weeks

If condition persists longer, consult a doctor

This product is not effective on the scalp or nails For athlete's foot:

  • pay special attention to the spaces between the toes
  • wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
Warnings and Precautions (34071-1)


Warnings

For external use only

Flammable:Contents under pressure. Do not puncture or incinerate or store at a temperature above 120 degrees F. Use only as directed. intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or while smoking.



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use

  • for diaper rash
  • on chuldren under 2 years of age

When using this product avoid contact with the eyes

S top use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch).

Section 51727-6 (51727-6)

Inactive ingredients acetone, ethoxydiglycol, propylene glycol, SD alcohol 40-B (74% w/w), tocopheryl acetate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?



Please Call 305-805-3456 (M-F 9:00-5:00 pm EST)

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredients:             Purpose

Miconazole Nitrate 2%..... Antifungal




Advanced Ingredient Data


Raw Label Data

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